Merck & Co's Arcoxia gets thumbs-down from FDA's Arthritis Advisory Committee

USA-based drug major Merck & Co says that the Food and Drug Administration's Arthritis Advisory Committee has voted against recommending the approval of its new painkiller Arcoxia (etoricoxib) for the symptomatic treatment of osteoarthritis. The vote was 20-one against approving the drug, with panel member Richard Cannon, a cardiologist with the National Heart, Lung and Blood Institute, commenting that "we do not have strong data that there is a need for this drug, compared to what's already available."

Arcoxia, which has been under review by the agency since 2003, is a selective COX-2 inhibitor. It has been dubbed the "offspring of Vioxx [rofecoxib]" by US consumer group Public Citizen, which argues that the agent is likely to be plagued by the same problems that led to Vioxx' withdrawal (Marketletters passim).

"Time to shut the door on COX-2 inhibitors" says Public Citizen